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Federal Register / Vol. 47, No. 167 / Friday, August 27, 1982 / Notices 
properties of the system which affect 
containment and utility, including 
information on yields of phage or 
plasmid molecules, ease of DNA 
isolation, and ease of transfection or 
transformation, (vi) In some cases, the 
investigator may be asked to submit 
data on survival and vector 
transmissibility h^m experiments in 
which the host-vector is fed to 
laboratory animals and human subjects. 
Such in vivo data may be required to 
confirm the validity of predicting in vivo 
survival on the basis of in vitro 
experiments. 
Data must be submitted in writing to 
ORDA. Ten to twelve weeks are 
normally required for review and 
circulation of the data prior to the 
meeting at which such data can be 
considered by the RAC. Investigators 
are encouraged to publish their data on 
the construction, properties, and testing 
of proposed HV2 systems prior to 
consideration of the system by the RAC 
and its subcommittee. More specific 
instructions concerning the type of data 
to be submitted to NIH for proposed EK2 
systems involving either plasmids or 
bacteriophage in E. coli K-12 are 
available from ORDA. 
Appendix I-m. — Footnotes and References of 
Appendix 1 
1. Hershfield, V., H. W. Boyer, C. Yanofsky, 
M. A. Lovett, and D. R. Helinski (1974). 
Plasmid ColEI as a Molecular Vehicle for 
Cloning and Amplification of DNA. Proc. Nat. 
Acad. Sci. USA 71. 3455-3459. 
2. Wensink, P. C., D. J. Finnegan, J. E. 
Donelson, and D. S. Hogness (1974). A System 
for Mapping DNA Sequences in the 
Chromosomes of Drosophila Melanogaster. 
Ceil 3, 315-335. 
3. Tanka, T., and B. Weisblum (1975). 
Construction of a Colicin El-R Factor 
Composite Plasmid In Vitro: Means for 
Amplification of Deoxyribonucleic Acid. J. 
Bacteriol. 121, 354-362. 
4. Armstrong, K. A., V. HershBeld, and D. 
R. Helinski (1977). Gene Cloning and 
Containment Properties of Plasmid Col El 
and Its Derivatives, Science 196, 172-174. 
5. Bolivar, F., R. L Rodriguez, M. C. Betlach, 
and H. W. Boyer (1977). Construction and 
Characterization of New Cloning Vehicles: I. 
Ampicillin-Resistant Derivative of pMB9. 
Gene 2. 75-93. 
0. Cohen, S. N., A. C. W. Chang, H. Boyer, 
and R. Helling (1973). Construction of 
Biologically Functional Bacteria! Plasmids in 
Vitro. Proc. Natl. Acad. Sci. USA 70, 3240- 
3244. 
7. Bolivar, F., R. L Rodriguez, R. J. Greene, 
M. C. Batlach, H. L. Reyneker, H. W. Boyer, J. 
H. Crosa, and S. Falkow (1977). Construction 
and Characterization of New Cloning 
Vehicles: II. A Multi-Purpose Cloning 
System. Gene 2, 95-113. 
8. Thomas, M., ). R. Cameron, and R. W. 
Davis (1974). Viable Molecular Hybrids of 
Bacteriophage Lambda and Eukaryotic DNA. 
Proc. Nat. Acad. Sci. USA 71, 4579-4583. 
9. Murray, N. E. and K. Murray (1974). 
Manipulation of Restriction Targets in Phage 
Lambda to Form Receptor chromosomes for - 
DNA Fragments. Nature 251, 476-481. 
10. Rambach, A., and P. Tiollais (1974). 
Bacteriophage Having EcoRI Endonuclease 
Sites Only in the Non-Essential Region of the 
Genome. Proc. Nat. Acad. Sci., USA 71, 3927- 
3930. 
11. Blattner, F. R., B. G. Williams. A. E. 
Bleche, K. Denniston-Thompson, H. E. Faber, 
L. A. Furlong, D. J. Gunwald, D. O. Kiefer, D. 
D. Moore, ). W. Shumm, E. L. Sheldon, and O. 
Smithies (1977). Charon Phages: Safer 
Derivatives of Bacteriophage Lambda for 
DNA Cloning. Science 196, 163-169. 
12. Donoghue, D. J., and P. A. Sharp (1977). 
An Improved Lambda Vector: Construction of 
Model Recombinants Coding for Kanamycin 
Resistance. Gene 1, 209-227. 
13. Leder, P., D. Tiemeier and L Enquist 
(1977). EK2 Derivatives of Bacteriophage 
Lambda Useful in the Cloning of DNA From 
Higher Organisms: The gt WES System. 
Science 196, 175-177. 
14. Skalka, A. (1978). Current Status of 
Coliphage EK2 Vectors. Gene 3, 29-35. 
15. Szybalski, W., A. Skalka, S. Gottesman, 
A. Campbell, and D. Botstein (1978). 
Standardized Laboratory Tests for EK2 
Certification. Gene 3, 36-38. 
Appendix J. — Federal Interagency 
Advisory Committee on Recombinant 
DNA Research 
Appendix J-I. The Federal Interagency 
Advisory Committee on Recombinant 
DNA Research advises the Secretary of 
the Department of Health and Human 
Services, the Assistant Secretary for 
Health, and the Director, National 
Institutes of Health, on the coordination 
of those aspects of all Federal programs 
and activities relating to recombinant 
DNA research. The Committee provides 
for communication and exchange of 
information necessary to maintain 
adequate coordination of such programs 
and activities. The Committee is 
responsible for facilitating compliance 
with a uniform set of guidelines in the 
conduct of this research in the public 
and private sectors and, where 
warranted, to suggest administrative or 
legislative proposals. 
The Director of the NIH, or his 
designee, serves as Chairman, and the 
Committee includes representation from 
all Departments and Agencies whose 
programs involve health functions or 
responsibilities as determined by the 
Secretary. 
Departments and Agencies which 
have representation on this Committee, 
as of December 1980, are: 
Department of Agriculture 
Department of Commerce 
Department of Defense 
Department of Energy 
Environmental Protection Agency 
Executive OfHce of the President 
Department of Health and Human Services 
OfHce of the Assistant Secretary for Health 
Centers for Disease Control 
Food and Drug Administration 
National Institutes of Health 
Department of the Interior 
Department of Justice 
Department of Labor 
National Aeronautics and Space 
Administration 
National Science Foundation 
Nuclear Regulatory Commission 
Department of State 
Department of Transportation 
Arms Control and Disarmament Agency 
Veterans Administration 
At the second meeting of the 
Committee on November 23, 1976, all of 
the Federal agencies endorsed the NIH 
Guidelines, and Departments which 
support or conduct recombinant DNA 
research agreed to abide by the NIH 
Guidelines [1]. 
Appendix J-D. Footnote of Appendix J 
1. Minutes of the first eight meetings of the 
Federal Interagency Advisory Committee on 
Recombinant DNA Research are reproduced 
in Recombinant DNA Research, Volume 2, 
Documents Relating to "NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules, "June 1976-November 1977. 
OMB’s "Mandatory Information 
Requirements for Federal Assistance Program 
Announcements" (45 FR 39592) requires a 
statement concerning the official government 
programs contained in the Catalog of Federal 
Domestic Assistance. Normally NIH lists in 
its announcements the number and title of 
affected individual programs for the guidance 
of the public. Because the guidance in this 
notice covers not only virtually every NIH 
program but also essentially every federal 
research program in which DNA recombinant 
molecule techniques could be used, it has 
been determined to be not cost effective or in 
the public interest to attempt to list these 
programs. Such a list would likely require 
several additional pages. In addition, NIH 
could not be certain that every federal 
program would be included as many federal 
agencies, as well as private organizations, 
both national and intemabonal, have elected 
to follow the NIH Guidelines. In lieu of the 
individual program listing, NIH invites 
readers to direct questions to the information 
address above about whether individual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
NIH programs are not covered by OMB 
Circular A-95 because they fit the description 
of "programs not considered appropriate” in 
Section 8-(b)-(4) and (5) of that Circular. 
Dated: August 18, 1982. 
Richard M. Krause, 
Director, National Institute of Allergy and 
Infectious Diseases, National Institutes 
of Health. 
[FR Doc. 82-23306 Plied S-2B-82; 8:45 am) 
HLUNG CODE 414O-01-M 
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